NCT04786977

Physiologic Measure of VIPN

Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is the development of a physiologic endpoint using a novel technology that would provide an objective, easy to use and more sensitive assessment of VIPN in children and adolescents. The ability to more easily detect and monitor VIPN, even before it is clinically evident, would facilitate optimizing the dosing of vincristine for maximal disease response while minimizing the risk of lifelong functional deficits affecting quality of life. This approach would also enable the development of specific therapies to minimize or eliminate the occurrence of VIPN in children and adolescents. This is a single site study that aims to develop a novel device to evaluate and characterize vincristine-induced neuropathic pain. The investigators will enroll patients with ALL following the Delayed Intensification (DI) phase of treatment. At each study visit, the investigators will evaluate the nPRD as well as the TNS-PV. The nPRD will inform the neuropathy index which will be used to compare to the TNS-PV. We anticipate a correlation between the two.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	No Intervention, Observational Study	No Intervention

Timeline

• Start date: 2021-09-20
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2021-03-08
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States